The following data is part of a premarket notification filed by Zest Anchors, Llc with the FDA for Turbotemp Ez.
| Device ID | K191619 |
| 510k Number | K191619 |
| Device Name: | TurboTemp EZ |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | Zest Anchors, LLC 2875 Loker Avenue East Carlsbad, CA 92010 |
| Contact | Marysa E. Loustalot |
| Correspondent | Marysa E. Loustalot Zest Anchors, LLC 2875 Loker Avenue East Carlsbad, CA 92010 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-18 |
| Decision Date | 2019-09-11 |
| Summary: | summary |